Rapid, sensitive, and validated HPLC method for analysis of metronidazole and tinidazole under identical chromatographic conditions with UV detection and liquid-liquid extraction: application in bioequivalence studies

• Autorzy: Emami J , Rezazadeh M
• Języki publikacji: EN

Abstrakty

EN

A simple, rapid, and sensitive reversed-phase HPLC method was developed and validated for determination of metronidazole and tinidazole in human plasma samples under identical chromatographic conditions. This method involves liquid-liquid extraction using chloroform: isopropylalcohol (95:5). Chromatographic separation was performed using a μ-bondapack C18 (250 mm × 4.6 mm) column. The mobile phase consisted of potassium dihydrogen phosphate solution (0.005 M)/acetonitrile (80/20 v/v). The final pH of the mobile phase was adjusted to 4 ± 0.1 with orthophosphoric acid. The calibration curves were linear over the concentration range 0.1–15 μg/mL for metronidazole and tinidazole with the detection limit of 30 ng/mL. Within- and between-day precision and accuracy did not exceed 9.83% and 10.48%, respectively. Metronidazole and tinidazole were found to be stable in plasma samples with no evidence of degradation during 3 freeze-thaw cycles and 3 months storage in −70 °C. The current validated bio-analytical method was finally applied in bioequivalence studies of two different metronidazole and tinidazole products according to a standard two-way cross-over design with a two-week washout period. No statistically significant difference was observed between the logarithmically transformed AUC0-∞ and Cmax values. Therefore, generic products were considered bioequivalent with those of standards which could be used interchangeably.

Słowa kluczowe

EN

metronidazole; tinidazole; HPLC; pharmacokinetics; bioavailability

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2013
• Tom: Vol. 25, no. 1
• Strony: 111--125
• Opis fizyczny: Bibliogr. 30 poz., rys., tab.

Twórcy

autor

Emami J

• Isfahan University of Medical Sciences Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences Isfahan Iran

autor

Rezazadeh M

• Isfahan University of Medical Sciences Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences Isfahan Iran

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